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Full text of "ASQC Q9001: Quality Assurance in Design, Development, Production, Installation, and Servicing"

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By Authority Of 

THE UNITED STATES OF AMERICA 

Legally Binding Document 



By the Authority Vested By Part 5 of the United States Code § 552(a) and 
Part 1 of the Code of Regulations § 51 the attached document has been duly 
INCORPORATED BY REFERENCE and shall be considered legally 
binding upon all citizens and residents of the United States of America. 
HEED THIS NOTICE : Criminal penalties may apply for noncompliance. 




Document Name: ASQC Q9001 : Quality Assurance in Design, Development 

Production, Installation, and Servicing 

CFR Section(s): 33 CFR Q6.430(a)(2)(ii) 



Standards Body: 



ANSI/ASQC Q9001 



ADOPTION NOTICE 

ANSI/ASQC Q9001 , "Quality Systems-Model for Quality Assurance in - Design, 
Development, Production, Installation, and Servicing," was adopted on 15 September 
1994 for use by the Department of Defense (DoD). Proposed changes by DoD 
activities must be submitted to the DoD Adopting Activity: Office of the Assistant 
Secretary of the Air Force for Acquisition, Deputy Assistant Secretary for Management 
Policy and Program Integration, Manufacturing and Quality Division, ATTN: 
SAF/AQXM, 1060 Air Force Pentagon, Washington, DC 20330-1060. DoD activities 
may obtain copies of this standard from the Standardization Document Order Desk, 700 
Robbins Avenue, Building 4D, Philadelphia, PA 19111-5094. The private sector and 
other Government agencies may purchase copies from The American Society for 
Quality Control, 61 1 East Wisconsin Avenue, Milwaukee, Wl 53202. 



Custodians: Adopting Activity: 

Army - AR Air Force - 05 

Navy - OS (Project QCIC-0185) 
Air Force - 05 



AREA QCIC 
DISTRIBUTION STATEMENT A : Approved for public release; distribution is unlimited. 



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ANSI/ASQCQ9001-1994 



AMERICAN NATIONAL STANDARD 



Quality Systems— Model for Quality Assurance 

in Design, Development, Production, 

Installation, and Servicing 



[Revision of first edition (ANSI/ASQC 091-1987)] 

Prepared by 
American Society for Quality Control Standards Committee 

for 
American National Standards Committee Z-1 on Quality Assurance 



An American National Standard Approved on August 1, 1994 



Descriptors: quality assurance, quality assurance program, quality systems, design, development (work), production, 
installation, after-sale services, reference models. 



American National Standards: An American National Standard implies a consensus of those substantially concerned with 
its scope and provisions. An American National Standard is intended as a guide to aid the manufacturer; the consumer, 
and the general public. The existence of an American National Standard does not in any respect preclude anyone, whether 
he or she has approved the standard or not, from manufacturing, purchasing, or using products, processes, or procedures 
not conforming to the standard. American National Standards are subject to periodic review and users are cautioned to 
obtain the latest edition. 

Caution Notice: This American National Standard may be revised or withdrawn at any time. The procedures of the 
American National Standards Institute require that action be taken to reaffirm, revise, or withdraw this standard no later 
than five years from the date of publication. Purchasers of American National Standards may receive current information 
on all standards by calling or writing the American National Standards Institute. 



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©1994byASQC 

All rights reserved. No part of this book may be reproduced in any form or by any means, electronic, mechanical, photo- 
copying, recording, or otherwise, without the prior written permission of the publisher 

ASQC Mission: 7b facilitate continuous improvement and increase customer satisfaction by identifying, communicating, 
and promoting the use of quality principles, concepts, and technologies; and thereby be recognized throughout the world 
as the leading authority cm, and champion fix; quality. 

10987654321 

Printed in the United States of America 

\$ (^o) Printed on acid-free recycled paper 

PuHiAed by: 

ASQC 

611 East Wisconsin Avenue 

Milwaukee, Wisconsin 53202 



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ANSI/ASQC Q9001-1994 



Contents 



Page 



1 Scope 

2 Normatne reference. 



3 Definitions 



Quality-system requirements. . , 

4.1 Management responsibility „ 

4.2 Quality system 2 

4.3 Contract review 3 

4.4 Design control . . . . ♦ 3 

4.5 Document and data control 4 

4.6 Purchasing 4 

4.7 Control of customer-supplied product 5 

4.8 Product identification and traceability 5 

4.9 Process control 5 

4.10 Inspection and testing 6 

4.11 Control of inspection, measuring, and test equipment 6 

4.12 Inspection and test status 7 

4.13 Control of nonconforming product 7 

4.14 Corrective and preventive action . , 8 

4.15 Handling, storage, packaging, preservation, and delivery 8 

4.16 Control of quality records 8 

4.17 Internal quality audits 9 

4.18 Thaning 9 

4.19 Servicing 9 

4.20 Statistical techniques 9 



Annex 

A Bibliography 



10 



in 



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Foreword 



(This Foreword is not a part of American National Standard Quality Systems— Model for Quality Assurance in Design, 
Development, Production, Installation, and Servicing.) 

This American National Standard corresponds to the International Standard ISO 9001:1994. The initial five ISO 9000 
series standards, ISO 9000, ISO 9001, ISO 9002, ISO 9003, and ISO 9004, when puMidied in the United States as 
American National Standards in 1987, were designated as ANSI/ASQC Q90 through ANSI/ASQC Q94 respectively. 
The five 1987 standards in their 1994 international revisions are now designated ISO 9000-1, ISO 9001, ISO 9002, 
ISO 9003, and ISO 9004-1 respectively. Their publication as American National Standards are now designated 
ANSI/ASQC Q9000-M994, ANSI/ASQC Q900M994, ANSVASQC Q9002-1994, ANSI/ASQC Q9003-1994, and 
ANSI/ASQC Q9004-1-1994 respectively. This new numbering system is intended to emphasize the word-for-word corre- 
spondence of the International and American National Standards. 

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO 
member bodies). The work of preparing International Standards is normally carried out through ISO technical commit- 
tees. Each member body interested in a subject for which a technical committee has been established has the right to be 
represented on that committee. International organizations, governmental and nongovernmental, in liaison with ISO, also 
take part in the work. ISO collaborates closely with the International Etectrotechnkal Commission (IEC) on all matters of 
etectrotechnkal standardization. The American National Standards Institute (ANSI) is the U.S. member body of ISO. 
ASQC is the U.S. member of ANSI responsible for quality management and related standards. 

Users should note that all ANSI/ASQC standards undergo revision from time to time. In the case of International 
Standards adopted as American National Standards, the revision timing is influenced by the international revision timing. 
Reference herein to any other standard implies the latest American National Standard revision unless otherwise stated. 

Comments concerning this standard are welcome. They should be sent to the sponsor of the standard, American Society 
for Quality Control, 611 East Wisconsin Avenue, P.O. Box 3005, Milwaukee, WI 53201-3005, c/o Standards 
Administrator 



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Introduction 

This American National Standard is one of three American National Standards dealing with quality-system requirements 
that can be used for external quality-assurance purposes. The quality-assurance models, set out in the three American 
National Standards listed below, represent three distinct forms of quality-system requirements suitable for the purpose of 
a supplier demonstrating its capability, and for the assessment of the capability of a supplier by external parties. 

a) ANSI/ASQC Q9001-1994, Quality Systems— Model for Quality Assurance in Design, Development, Production, 
Installation, and Servicing 

— for use when conformance to specified requirements is to be assured by the supplier during design, development, 
production, installation, and servfcii^. 

b) ANSI/ASQC Q9002-1994, Quality Systems—Model for Quality Assurance in Production, Installation, and Servicing 

— for use when conformance to specified requirements is to be assured by the supplier during production, installa- 
tion, and servicing, 

c) ANSI/ASQC Q9003-1994, Quality Systems— Model for Quality Assurance in Final Inspection and Test 

— for use when conformance to specified requirements is to be assured by the supplier solely at final inspection and 
test 

It is emphasized that the quality-system requirements specified in this American National Standard, ANSI/ASQC Q9002- 
1994, and ANSI/ASQC Q9003-1994 are complementary (not alternative) to the technical (product) specified require- 
ments. They specify requirements which determine what elements quality systems have to encompass, but it is not the 
purpose of these American National Standards to enforce uniformity of quality systems. They are generic and indepen- 
dent of any specific industry or economic sector The design and implementation of a quality system will be influenced by 
the varying needs of an organization, its particular objectives, the products and services supplied, and the processes and 
specific practices employed. 

It is intended that these American National Standards will be adopted in their present form, but on occasions they may 
need to be tailored by adding or deleting certain quality-system requirements for specific contractual situations. 
ANSI/ASQC Q9000-1-1994 provides guidance on such tailoring as well as on selection of the appropriate quality- 
assurance model, viz. ANSI/ASQC Q9001-1994, ANSI/ASQC Q9002-1994, or ANSI/ASQC Q9003-1994. 



vn 



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ANSI/ASQCQ9001-1994 

QUALITY SYSTEMS— MODEL FOR QUALITY ASSURANCE IN DESIGN, 
DEVELOPMENT, PRODUCTION, INSTALLATION, AND SERVICING 



1 SCOPE 

This American National Standard specifies quality-system 
requirements for use where a supplier's capability to 
design and supply conforming product needs to be 
demonstrated 

The requirements specified are aimed primarily at achiev- 
ing customer satisfaction by preventing noncxMiformity at 
all stages from design through to servicing. 

This American National Standard is applicable in situa- 
tions when 

a) design is required and the product requirements are 
stated principally in performance terms, or they need 
to be established, and 

b) confidence in product conformance can be attained by 
adequate demonstration of a supplier's capabilities in 
design, development, production, installation, and 
serviciiig. 

NOTE 1 For informative references, see annex A. 

2 NORMATIVE REFERENCE 

The following standard contains provisions which, 
through reference in this text, constitute provisions of this 
American National Standard. At the time of publication, 
the edition indicated was valid. All standards arc subject 
to revision, and parties to agreements based on this 
American National Standard are encouraged to investigate 
the possibility of applying the most recent edition of the 
standard indicated below. The American National 
Standards Institute and members of IEC and ISO main- 
tain registers of currently valid American National 
Standards and International Standards. 

ISO 8402:1994, Quality management and quality assur- 
ance — Vocabulary. 

3 DEFINITIONS 

For the purposes of this American National Standard, the 
definitions given in ISO 8402 and the following definitions 

apply. 

3*1 product: Result of activities or processes, 
NOTES 

2 A product may include service, hardware, processed 
materials, software, or a combination thereof. 



3 A product can be tangible (e.g., assemblies or 
processed materials) or intangible (e.g., knowledge or 
concepts), or a combination thereof 

4 For the purposes of this American National Standard, 
the term **producr applies to the intended product 
offering only and not to unintended "by-products" 
affecting the environment This differs from the defini- 
tion given in ISO 8402. 

3,2 tender: Offer made by a supplier in response to an 
invitation to satisfy a contract award to provide product 

3*3 contract; accepted order: Agreed requirements 
between a supplier and customer transmitted by any 
means. 

4 QUALITY-SYSTEM REQUIREMENTS 

4.1 Management responsibility 

4.1.1 Quality policy 

The supplier's management with executive responsibility 
shall define and document its policy for quality, including 
objectives for quality and its commitment to quality. The 
quality policy shall be relevant to the supplier's organiza- 
tional goals and the expectations and needs of its cus- 
tomers. The supplier shall ensure that this policy is 
understood, implemented, and maintained at all lewis of 
the organization. 

4.1.2 Organization 

4.1.2.1 Responsibility and authority 

The responsibility, authority, and the interrelation of per- 
sonnel who manage, perform, and verify work affecting 
quality shall be defined and documented, particularly for 
personnel who need the organizational freedom and 
authority to: 

a) initiate action to prevent the occurrence of any non- 
conformities relating to product, process, and quality 
system; 

b) identify and record any problems relating to the prod- 
uct, process, and quality system; 



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ANSI/ASQCQ900M994 



c) initiate, recommend, cm* provide solutions through des- 
ignated channels; 

d) verify the implementation of solutions; 

e) control further processing, delivery, or installation of 
nonconforming product until the deficiency or unsatis- 
factory condition has been corrected. 

4,1.2.2 Resources 

The supplier shall identify resource requirements and pro- 
vide adequate resources, including the assignment of 
trained personnel (see 4.18), for management, perfor- 
mance of work, and verification activities including inter- 
nal quality audits. 

4.1*2.3 Management representative 

The supplier's management with executive responsibility 
shall appoint a member of the supplier's own management 
who, irrespective of other responsibilities, shall have 
defined authority far 

a) ensuring that a quality system is established, imple- 
mented, and maintained in accordance with this 
American National Standard, and 

b) reporting on the performance of the quality system to 
the supplier's management for review and as a basis for 
improvement of the quality system. 

NOTE 5 The responsibility of a management represen- 
tative may also include liaison with external parties on 
matters relating to the supplier's quality system. 

4.13 Management review 

The supplier's management with executive responsibility 
Aall review the quality system at defined intervals suffi- 
cient to ensure its continuing suitability and effectiveness 
in satisfying the requirements of this American National 
Standard and the supplier's stated quality policy and 
objectives (see 4.1.1). Records of such reviews shall be 
maintained (see 4.16). 

42 QUALITY SYSTEM 

4*2.1 General 

The supplier shall establish, document, and maintain a 
quality system as a means of ensuring that product con- 
forms to specified requirements. The supplier tfiall prepare 
a quality manual covering the requirements of this 
American National Standard. The quality manual shall 
include or make reference to the quality-system procedures 



and outline the structure of the documentation used in 
the quality system. 

NOTE 6 Guidance on quality manuals is given in ISO 
10013. 

422 Quality-system procedures 

The supplier shall 

a) prepare documented procedures consistent with the 
requirements of this American National Standard and 
the supplier's stated quality policy; and 

b) effectively implement the quality system and its docu- 
mented procedures. 

For the purposes of this American National Standard, the 
range and detail of the procedures that farm part of the 
quality system depend on the complexity of the work, the 
methods used, and the skills and training needed by per- 
sonnel involved in carrying out the activity. 

NOTE 7 Documented procedures may make reference 
to work instructions that define how an activity is 
performed. 

423 Quality planning 

The supplier shall define and document how the require- 
ments far quality will be met Quality planning shall be 
consistent with all other requirements of a supplier's qual- 
ity system and shall be documented in a format to suit the 
supplier's method of operation. The supplier shall give 
consideration to the following activities, as appropriate, in 
meeting the specified requirements far products, projects, 
or contracts: 

a) the preparation of quality plans; 

b) the identification and acquisition of any controls, 
processes, equipment (including inspection and test 
equipment), fixtures, resources, and skills that may be 
needed to achieve the required quality; 

c) ensuring the compatibility of the design, the produc- 
tion process, installation, servicing, inspection, and test 
procedures, and the applicable documentation; 

d) the updating, as necessary, of quality control, inspec- 
tion, and testing techniques, including the development 
of new instrumentation; 

e) the identification of any measurement requirement 
involving capability that exceeds the known state of the 
art, in sufficient time far the needed capability to be 

developed; 



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ANSI/ASQCQ9001-1994 



f) the identification of suitable verification at appropriate 
stages in the realization of product; 

g) the clarification of standards of acceptability for all 
features and requirements, including those which con- 
fain a subjective element; 

h) the identification and preparation of quality records 
(see 4.16). 

NOTE 8 The quality plans referred to (see 4.2.3a) may 
be in the form of a reference to the appropriate docu- 
mented procedures that form an integral part of the sup- 
plier's quality system. 

43 CONTRACT REVIEW 

43.1 General 

The supplier shall establish and maintain documented 
procedures for contract review and for the coordination of 
these activities. 

432 Review 

Before submission of a tender or at the acceptance of a 
contract or order (statement of requirement), the tender, 
contract or order shall be reviewed by the supplier to 
ensure that: 

a) the requirements are adequately defined and docu- 
mented; where no written statement of requirement is 
available for an order received by verbal means, the 
supplier shall ensure that the order requirements are 
agreed before their acceptance; 

b) any differences between the contract or accepted order 
requirements and those in the tender are resolved; 

c) the supplier has the capability to meet the contract or 
accepted order requirements. 

433 Amendment to contract 

The supplier shall identify how an amendment to a con- 
tract is made and correctly transferred to the functions 
concerned within the supplier's organization. 

4.3,4 Records 

Records of contract reviews shall be maintained (see 
4.16). 

NOTE 9 Channels for communication and interfaces 
with the customer's organization in these contract matters 
should be established. 



4.4 DESIGN CONTROL 

4.4.1 General 

The supplier shall establish and maintain documented 
procedures to control and verify the design of the prod- 
uct in order to ensure that the specified requirements are 
met. 

4.4 2 Design and development planning 

The supplier shall prepare plans for each design and 
development activity. The plans shall describe or reference 
these activities, and define responsibility for their imple- 
mentation. The design and development activities shall be 
assigned to qualified personnel equipped with adequate 
resources. The plans shall be updated, as the design 
evolves. 

4.43 Organizational and technical interfaces 

Organizational and technical interfaces between different 
groups which input into the design process shall be 
defined and the necessary information documented* trans- 
mitted, and regularly reviewed 

4.4.4 Design input 

Design-input requirements relating to the product, includ- 
ing applicable statutory and regulatory requirements, shall 
be identified, documented, and their selection reviewed by 
the supplier far adequacy. Incomplete, ambiguous, or con- 
flicting requirements shall be resolved with those respon- 
sible for imposing these requirements. 

Design input shall take into consideration the results of 
any contract-review activities. 

4*4*5 Design output 

Design output shall be documented and expressed in 
terms that can be verified against design-input require- 
ments and validated (see 4.4.8). 

Design output shall: 

a) meet the design-input requirements; 

b) contain or make reference to acceptance criteria; 

c) identify those characteristics of the design that are cru- 
cial to the safe and proper functioning of the product 
(e.g„ operating, storage, handling, maintenance, and 
disposal requirements). 

Design-output documents shall be reviewed before 
release. 



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ANS/ASQCQ9001-1994 



4.4,6 Design review 

At appropriate stages of design, formal documented reviews 
of the design results shall be planned and conducted. 
Participants at each design review shall include representa- 
tives of all functions concerned with the design stage being 
reviewed, as well as other specialist personnel, as required 
Records of such reviews shall be maintained (see 4.16). 

4.4J Design verification 

At appropriate stages of design, design verification shall 
be performed to ensure that the design-stage output meets 
the design-stage input requirements. The design-verifica- 
tion measures shall be recorded (see 4.16). 

NOTE 10 In addition to conducting design reviews (see 
4.4.6), design verification may include activities such as 

— performing alternative calculations, 

— comparing the new design with a similar proven 
design, if available, 

— undertaking tests and demonstrations, and 

— reviewing the design-stage documents before release. 

4 .4.8 Design validation 

Design validation shall be performed to ensure that prod- 
uct conforms to defined user needs and/or requirements. 

NOTES 

11 Design validation follows successful design verifica- 
tion (see 4.4.7). 

12 Validation is normally performed under defined 
operating conditions. 

13 Widation is normally performed on the final prod- 
uct, but may be necessary in earlier stages prior to 
product completion. 

14 Multiple validations may be performed if there are 
different intended uses. 

4.4.9 Design changes 

All design changes and modifications shall be identified, 
documented, reviewed, and approved by authorized per- 
sonnel before their implementation. 

4*5 DOCUMENT AND DATA CONTROL 

4.5.1 General 

The supplier shall establish and maintain documented 
procedures to control all documents and data that relate to 
the requirements of this American National Standard 



including, to the extent applicable, documents of external 
origin such as standards and customer drawings. 

NOTE 15 Documents and data can be in the form of 
any type of media, such as hard copy or electronic media. 

4.5 2 Document and data approval and issue 

The documents and data shall be reviewed and approved 
for adequacy by authorized personnel prior to issue. A 
master list or equivalent document-control procedure 
identifying the current revision status of documents shall 
be established and be readily available to preclude the use 
of invalid and/or obsolete documents. 

This control shall ensure that: 

a) the pertinent issues of appropriate documents are 
available at all locations where operations essential 
to the effective functioning of the quality system are 
performed; 

b) invalid and/or obsolete documents are promptly 
removed from all points of issue or use, or otherwise 
assured against unintended use; 

c) any obsolete documents retained for legal and/or 
knowledge-preservation purposes are suitably identified. 

4.5 3 Document and data changes 

Changes to documents and data shall be reviewed and 
approwd by the same functions/organizations that per- 
formed the original review and approval, unless specifi- 
cally designated otherwise. The designated functions/ 
organizations diall have access to pertinent background 
information upon which to base their review and approval . 

Where practicable, the nature of the change rfiall be iden- 
tified in the document or the appropriate attachments. 

4.6 PURCHASING 

4*6*1 General 

The supplier shall establish and maintain documented 
procedures to ensure that purchased product (see 3,1) 
conforms to specified requirements. 

4.6*2 Evaluation of subcontractors 

The supplier shall: 

a) evaluate and select subcontractors on the basis of their 
ability to meet subcontract requirements including the 
quality system and any specific quality-assurance 
requirements; 



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ANSI/ASQCQ9001-1994 



b) define the type and extent of control exercised by the 
supplier o\er subcontractors. This shall be dependent 
upon the type of product, the impact of subcontracted 
product on the quality of final product, and, where 
applicable, on the quality audit reports and/or quality 
records of the previously demonstrated capability and 
performance of subcontractors; 

c) establish and maintain quality records of acceptable 
subcontractors (see 4.16). 

4jS3 Purchasing data 

Purchasing documents shall contain data clearly describ- 
ing the product ordered, including where applicable: 

a) the type, class, grade, or other precise identification; 

b) the title or other positive identification, and applicable 
issues of specifications, drawings, process require- 
ments, inspection instructions, and other relevant tech- 
nical data, including requirements for approval or 
qualification of product, procedures, process equip- 
ment, and personnel; 

c) the title, number; and issue of the quality-system stan- 
dard to be applied. 

The supplier shall review and approve purchasing docu- 
ments for adequacy of the specified requirements prior to 
release. 

4.6*4 Verification of purchased product 

4.6.4.1 Supplier verification at subcontractor's 
premises 

Where the supplier proposes to \erify purchased product 
at the subcontractor's premises, the supplier shall specify 
verification arrangements and the method of product 
release in the purchasing documents. 

4.6.4.2 Customer verification of subcontracted 
product 

Where specified in the contract, the supplier's customer or 
the customer's representative diall be afforded the right to 
verify at the subcontractor's premises and the supplier's 
premises that subcontracted product conforms to specified 
requirements. Such verification shall not be used by the 
supplier as evidence of effective control of quality by the 
subcontractor 

\ferification by the customer diall not absolve the supplier 
of the responsibility to provide acceptable product, nor 
shall it preclude subsequent rejection by the customer: 



4.7 CONTROL OF CUSTOMER-SUPPLIED 
PRODUCT 

The supplier shall establish and maintain documented 
procedures for the control of verification, storage, and 
maintenance of customer-supplied product provided for 
incorporation into the supplies or for related activities. 
Any such product that is lost, damaged, or \s otherwise 
unsuitable for use shall be recorded and reported to the 
customer (see 4.16). 

Vferificadon by the supplier does not absolve the customer 
of the responsibility to provide acceptable product 

4.8 PRODUCT IDENTIFICATION AND 
TRACEABILITY 

Where appropriate, the supplier shall establish and main- 
tain documented procedures for identifying the product 
by suitable means from receipt and during all stages of 
production, delivery, and installation. 

Where and to the extent that traceability is a specified 
requirement, the supplier shall establish and maintain doc- 
umented procedures for unique identification of individual 
product or batches. This identification shall be recorded 
(see 4.16), 

4.9 PROCESS CONTROL 

The supplier shall identify and plan the production, 
installation, and servicing processes which directly aflect 
quality and shall ensure that these processes are carried 
out under controlled conditions. Controlled conditions 
shall include the following: 

a) documented procedures defining the manner of pro- 
duction, installation, and servicing, where the 
absence of such procedures could adversely affect 
quality; 

b) use of suitable production, installation, and servicing 
equipment, and a suitable working environment; 

c) compliance with reference standards/codes, quality 
plans, and/or documented procedures; 

d) monitoring and control of suitable process parameters 
and product characteristics; 

e) the approval of processes and equipment, as appropriate'* 

f) criteria for workmanship, which shall be stipulated in 
the clearest practical manner (e.g., written standards, 
representative samples, or illustrations); 

g) suitable maintenance of equipment to ensure continu- 
ing pocess capability. 



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ANSVASQCQ9001-1994 



Where the results of processes cannot be fully verified by 
subsequent inspection and testing of the product and 
where, for example, processing deficiencies may become 
apparent only after the product is in use, the processes 
shall be carried out by qualified operators and/or shall 
require continuous monitoring and control of process para- 
meters to ensure that the specified requirements are met 

The requirements for any qualification of process opera- 
tions, including associated equipment and personnel (see 
4.18), shall be specified 

NOTE 16 Such processes requiring prequalification of 
their process capability are frequently referred to as spe- 
cial processes. 

Records shall be maintained for qualified processes, 
equipment, and personnel, as appropriate (see 4. 16). 

4,10 INSPECTION AND TESTING 

4.10.1 General 

The supplier shall establish and maintain documented 
procedures fix inspection and testing activities in order to 
verify that the specified requirements for the product are 
met. The required inspection and testing, and the records 
to be established, shall be detailed in the quality plan or 
documented procedures. 

4.10 2 Receiving inspection and testing 

4.10.2.1 The supplier diall ensure that incoming product is 
hot used or processed (except in the circumstances 
described in 4.10.23) until it has been inspected or other- 
wise verified as conforming to specified requirements. 
Verification of the specified requirements shall be in accor- 
dance with the quality plan and|/or documented procedures. 

4.10*2.2 In determining the amount and nature of receiv- 
ing inspection, conaderatkxi shall be gi\en to the amount 
of control exercised at the subcontractor's premises and 
the recorded evidence of conformance provided. 

4.10*2 J Where incoming product is released fix urgent 
production purposes prior to verification, it shall be posi- 
tively identified and recorded (see 4 . 16) in order to permit 
immediate recall and replacement in the event of noncon- 
formity to specified requirements. 

4.103 In-process inspection and testing 

The supplier shall: 

a) inspect and test the product as required by the quality 
{dan and/or documented procedures; 



b) hold product until the required inspectiou and tests 
have been completed or necessary reports have been 
received and verified, except when product is released 
under positive-recall procedures (see 4.10.2.3). 
Release under positive-recall procedures shall not pre- 
clude the activities outlined in 4.10.3a. 

4.10.4 Final inspection and testing 

The supplier shall carry out all final inspection and test- 
ing in accordance with the quality plan and/or docu- 
mented procedures to complete the evidence of 
conformance of the finished product to the specified 
requirements. 

The quality plan and/or documented procedures for final 
inspection and testing shall require that all specified 
inspection and tests, including those specified either on 
receipt of product or in-process, have been carried out and 
that the results meet specified requirements. 

No product shall be dispatched until all the activities spec- 
ified in the quality plan and/or documented procedures 
have been satisfactorily completed and the associated data 
and documentation are available and authorized. 

4 .10.5 Inspection and test records 

The supplier shall establish and maintain records which 
provide evidence that the product has been inspected 
and/or tested. These records shall show clearly whether 
the product has passed or failed the inspections and/or 
tests according to defined acceptance criteria. Where the 
product fails to pass any inspection and/or test, the proce- 
dures fen: control of nonconforming product shall apply 
(see 4.13). 

Records shall identify the inspection authority responsible 
for the release of product (see 4.16). 

4.11 CONTROL OF INSPECTION, MEASURING, 
AND TEST EQUIPMENT 

4,11,1 General 

The supplier shall establish and maintain documented 
procedures to control, calibrate, and maintain inspection, 
measuring, and test equipment (including test software) 
used by the supplier to demonstrate the conformance of 
product to the specified requirements. Inspection, measur- 
ing, and test equipment shall be used in a manner which 
ensures that the measurement uncertainty is known and is 
consistent with the required measurement capability. 



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Where test software or comparative references such as test 
hardware are used as suitable forms of inspection, they 
shall be checked to prove that they are capable of verify- 
ing the acceptability of product, prior to release for use 
during production, installation, or servicing, and shall be 
rechecked at prescribed intervals. The supplier shall 
establish the extent and frequency of such checks and 
shall maintain records as evidence of control (see 4.16). 

Where the availability of technical data pertaining to the 
measurement equipment is a specified requirement, such 
data shall be made available, when required by the cus- 
tomer or customer's representative, for verification that the 
measuring equipment is functionally adequate. 

NOTE 17 For the purposes of this American National 
Standard, the term "measuring equipment" includes mea- 
surement devices. 

4.11.2 Control procedure 
The supplier shall: 

a) determine the measurements to be made and the accu- 
racy required, and select the appropriate inspection, 
measuring, and test equipment that is capable of the 
necessary accuracy and precision; 

b) identify all inspection, measuring, and test equipment 
that can affect product quality, and calibrate and adjust 
them at prescribed intervals, or prior to use, against 
certified equipment having a known valid relationship 
to internationally or nationally recognized standards. 
Where no such standards exist, the basis used for cali- 
bration shall be documented; 

c) define the process employed for the calibration of 
inspection, measuring, and test equipment, including 
details of equipment type, unique identification, loca- 
tion, frequency of checks, check method, acceptance 
criteria, and the action to be taken when results are 
unsatisfactory; 

d) identify inspection, measuring, and test equipment 
with a suitable indicator or approved identification 
record to show the calibration status; 

e) maintain calibration records for inspection, measuring, 
and test equipment (see 4.16); 

assess and document the validity of previous inspec- 
tion and test results when inspection, measuring, and 
test equipment is found to be out of calibration; 

g) ensure that the environmental conditions are suitable 
fear the calibrations, inspections, measurements, and 
tests being carried out; 



h) ensure that the handling, preservation, and storage of 
inspection, measuring, and test equipment is such that 
the accuracy and fitness for use are maintained; 

i) safeguard inspection, measuring, and test facilities, 
including both test hardware and test software, from 
adjustments which would invalidate the calibration 
setting. 

NOTE 18 The metrologkal confirmation system for 
measuring equipment given in ISO 10012 may be used 
for guidance. 

4.12 INSPECTION AND TEST STATUS 

The inspection and test status of product shall be identi- 
fied by suitable means, which indicate the conformance or 
nonconformance of product with regard to inspection and 
tests performed. The identification of inspection and test 
status shall be maintained, as defined in the quality plan 
and/or documented procedures, throughout production, 
installation, and servicing of the product to ensure that 
only product that has passed the required inspections and 
tests [or released under an authorized concession (see 
4.13.2)] is dispatched, used, or installed. 

4.13 CO^^raOLOFNONCONFOR^fINGPR(M)UCT 

4.13.1 General 

The supplier shall establish and maintain documented 
procedures to ensure that product that does not conform 
to specified requirements is prevented from unintended 
use or installation. This control shall provide for identifi- 
cation, documentation, evaluation, segregation (when 
practical), disposition of nonconforming product, and for 
notification to the functions concerned. 

4.13*2 Review and disposition of nonconforming 
product 

The responsibility for review and authority for the dispo- 
sition of nonconforming product shall be defined. 

Nonconforming product shall be reviewed in accordance 
with documented procedures. It may be 

a) reworked to meet the specified requirements, 

b) accepted with or without repair by concession, 

c) regraded for alternative applications, or 

d) rejected or scrapped. 

Where required by the contract, the proposed use or 
repair of pioduct (see 4.13.2b) which does not conform to 



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ANSI/ASQCQ9001-1994 



specified requirements diall be reported for concession to 
the customer or customer's representative. The description 
of the nonconformity that has been accepted, and of 
repairs, shall be recorded to denote the actual condition 

(see 4.16), 

Repaired and/or reworked product shall be reinspected 
in accordance with the quality plan and/or documented 
procedures. 

4.14 CORRECTIVE AND PREVENTIVE ACTION 

4.14*1 General 

The supplier shall establish and maintain documented 
procedures for implementing corrective and preventive 
action. 

Any corrective or preventive action taken to eliminate the 
causes of actual or potential nonconformities shall be to a 
degree appropriate to the magnitude of problems and 
commensurate with the risks encountered. 

The supplier shall implement and record any changes to 
the documented procedures resulting from corrective and 
preventive action. 

4.14.2 Corrective action 

The procedures far corrective action diall include: 

a) the effective handling of customer complaints and 
reports of product nonconformities; 

b) investigation of the cause of nonconformities relating to 
product, process, and quality system, and recording the 
results of the inve&igation (see 4.16); 

c) determination of the corrective action needed to elimi- 
nate the cause of nonconformities; 

d) application of controls to ensure that corrective action 
is taken and that it is effective. 

4.14 J Preventive action 

The piocedures for preventive action rfiall include: 

a) the use of appropriate sources of information such as 
processes and work operations which affect product 
quality, concessions, audit results, quality records, ser- 
vice reports, and customer complaints to detect, ana- 
lyze, and eliminate potential causes of nonconformities; 

b) determination of the steps needed to deal with any 
problems requiring preventive action; 

c) initiation of preventive action and application of con- 
trols to ensure that it is effecthe; 



d) confirmation that relevant information on actions taken 
is submitted for management review (see 4.1.3). 

4.15 HANDLING, STORAGE, PACKAGING, 
PRESERVATION, AND DELIVERY 

4*15.1 General 

The supplier shall establish and maintain documented 
procedures for handling, storage, packaging, preservation, 
and delivery of product 

4.15.2 Handling 

The supplier shall provide methods of handling product 
that pre\ent damage or deterioration. 

4.15.3 Storage 

The supplier shall use designated storage areas or stock 
rooms to prevent damage or deterioration of product, 
pending use or delivery. Appropriate methods for autho- 
rizing receipt to and dispatch from such areas shall be 
stipulated. 

In order to detect deterioration, the condition of product in 
stock shall be assessed at appropriate intervals. 

4.15»4 Packaging 

The supplier shall control packing, packaging, and mark- 
ing processes (including materials used) to the extent nec- 
essary to ensure conformance to specified requirements. 

4.15*5 Preservation 

The supplier shall apply appropriate methods for preser- 
vation and segregation of product when the product is 
under the supplier's control. 

4.15.6 Delivery 

The supplier shall arrange for the protection of the quality 
of product after final inspection and test Where contrac- 
tually specified, this protection shall be extended to 
include deli\ery to destination. 

4.16 CONTROL OF QUALITY RECORDS 

The supplier shall establish and maintain documented 
procedures for identification, collection, indexing, access, 
filing, storage, maintenance, and disposition of quality 
records. 

Quality records tfiall be maintained to demonstrate con- 
formance to specified requirements and the effective 



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ANSI/ASQC Q9001-1994 



operation of the quality system. Pertinent quality records 
from the subcontractor shall be an element of these 
data. 

All quality records shall be legible and shall be stored and 
retained in such a way that they are readily retrievable in 
facilities that provide a suitable environment to prevent 
damage or deterioration and to prevent loss. Retention 
times of quality records shall be established and recorded. 
Where agreed contractually, quality records shall be made 
available for evaluation by the customer or the customer's 
representative for an agreed period. 

NOTE 19 Records may be in the form of any type of 
media, such as hard copy or electronic media. 

4.17 INTERNAL QUALITY AUDITS 

The supplier shall establish and maintain documented 
procedures for planning and implementing internal quality 
audits to verify whether quality activities and related 
results comply with planned arrangements and to deter- 
mine the effectiveness of the quality system. 

Internal quality audits shall be scheduled on the baas of 
the status and importance of the activity to be audited 
and shall be carried out by personnel independent of 
those having direct responsibility for the activity being 
audited. 

The results of the audits shall be recorded (see 4.16) and 
brought to the attention of the personnel having responsi- 
bility in the area audited. The management personnel 
responsible for the area shall take timely correcthe action 
on deficiencies found durir^ the audit 

Follow-up audit activities shall verify and record the 
implementation and effectiveness of the corrective action 
laken (see 4, 16). 



NOTES 

20 The results of internal quality audits form an integral 
part of the input to management review activities 
(see 4.1.3). 

21 Guidance on quality-system audits is given in 
ANSI/ASQC Q1001 1-1-1994, ANSI/ASQC 
Q10011-2-1994, and ANSI/ASQC Q1001 1-3-1994. 

4.18 TRAINING 

The supplier shall establish and maintain documented 
procedures for identifying training needs and provide for 
the training of all personnel performing activities affecting 
quality, ftrsonnel performing specific assigned tasks shall 
be qualified on the basis of appropriate education, training 
and/or experience, as required. Appropriate records of 
training shall be maintained (see 4.16). 

4.19 SERVICING 

Where servicing is a specified requirement, the supplier 
shall establish and maintain documented procedures for 
performing, verifying, and reporting that the servicing 
meets the specified requirements. 

420 STATISTICAL TECHNIQUES 

4.20.1 Identification of need 

The supplier diall identify the need for statistical tech- 
niques required for establishing, controlling, and verifying 
process capability and product characteristics. 

4.20.2 Procedures 

The supplier shall establish and maintain documented 
procedures to implement and control the application of the 
statistical techniques identified in 4.20.1. 



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ANSI/ASQC Q9001-1994 

ANNEX A (INFORMATIVE) 
BIBLIOGRAPHY 



[1] ANSI/ASQC Q9000-l-1994 t Quality Management and Quality Assurance Standards — Guidelines for Selection 
and Use. 

[2] ANSI/ASQC Q9002-1994, Quality Systems— Model for Quality Assurance in Production, Installation, and 
Servicing. 

[3] ANSI/ASQC Q9003- 1994, Quality Systems— Model for Quality Assurance in Final Inspection and Test, 

[4] ANSI/ASQC Q1001M-1994, Guidelines for Auditing Quality Systems— Auditing. 

[5] ANSI/ASQC Q10011-2-1994, Guidelines for Auditing Quality Systems— Qualification Criteria for Quality 
Systems Auditors. 

[6] ANSI/ASQC Q1001 1-3-1994, Guidelines for Auditing Quality Systems— Management of Audit Programs. 

[7] ISO 9000-2:1993, Quality management and quality assurance standards— Part 2: Generic guidelines for the 
application of ISO 9001, ISO 9002 and ISO 9003. 

[8] ISO 9000-3:1991, Quality management and quality assurance standards— Part 3: Guidelines for the application 
of ISO 9001 to the development, supply and maintenance of software. 

[9] ISO 10012-1: 1992, Quality assurance requirements for measuring equipment— Part 1: Metrological confirmation 
system for measuring equipment, 

[10] ISO 10013: — t Guidelines for developing quality manuals. 



D lb be published. 



10 



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